• chevron_right

      FDA authorizes Pfizer’s COVID-19 vaccine for 12- to 15-year-olds

      Beth Mole · news.movim.eu / ArsTechnica · Monday, 10 May, 2021 - 23:08

    An illustration picture shows vials with COVID-19 Vaccine stickers attached, with the logo of US pharmaceutical company Pfizer, on November 17, 2020.

    Enlarge / An illustration picture shows vials with COVID-19 Vaccine stickers attached, with the logo of US pharmaceutical company Pfizer, on November 17, 2020. (credit: Getty | JUSTIN TALLIS )

    The US Food and Drug Administration has authorized the use of the Pfizer-BioNTech COVID-19 vaccine in adolescents between the ages of 12 to 15, the agency announced Monday evening .

    In the announcement, acting FDA Commissioner Janet Woodcock called the authorization “a significant step in the fight against the COVID-19 pandemic” that will bring the country “closer to returning to a sense of normalcy and to ending the pandemic.”

    Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, echoed that sentiment. He called the ability to vaccinate children and teens “a critical step” in the fight against COVID-19.

    Read 7 remaining paragraphs | Comments

    index?i=RpF5sjz2hv8:XvGzkBfQIto:V_sGLiPBpWUindex?i=RpF5sjz2hv8:XvGzkBfQIto:F7zBnMyn0Loindex?d=qj6IDK7rITsindex?d=yIl2AUoC8zA
    • chevron_right

      AstraZeneca’s troubled vaccine not renewed in EU; Pfizer gets big, new deal

      Beth Mole · news.movim.eu / ArsTechnica · Monday, 10 May, 2021 - 17:16

    Vials with COVID-19 Vaccine labels showing logos of pharmaceutical company Pfizer and German biotechnology company BioNTech.

    Enlarge / Vials with COVID-19 Vaccine labels showing logos of pharmaceutical company Pfizer and German biotechnology company BioNTech. (credit: Getty | Photonews )

    The European Union has declined to renew orders for AstraZeneca’s COVID-19 vaccine, an EU official said Sunday. The decision comes after a series of production and safety troubles with AstraZeneca’s vaccine—and news on Saturday that the EU signed a deal to have Pfizer and BioNTech provide up to 1.8 billion doses of their vaccine between 2021 and 2023.

    Last month, the EU took legal action against AstraZeneca, alleging that the company had failed to live up to its contract to supply the bloc with doses. The contract ends in June.

    "We did not renew the order after June,” European Internal Market Commissioner Thierry Breton said in a Sunday French radio interview, which was reported by Reuters . “We’ll see what happens," he added, leaving open the possibility of future orders.

    Read 12 remaining paragraphs | Comments

    index?i=67pY0_1PRag:Z56M2EjbgEE:V_sGLiPBpWUindex?i=67pY0_1PRag:Z56M2EjbgEE:F7zBnMyn0Loindex?d=qj6IDK7rITsindex?d=yIl2AUoC8zA
    • chevron_right

      Pfizer vaccine rollout might get a lot easier—ultra-cold storage not required

      Beth Mole · news.movim.eu / ArsTechnica · Friday, 19 February, 2021 - 21:47

    A picture taken on January 15, 2021 shows a pharmacist holding with gloved hands a vial of the undiluted Pfizer-BioNTech vaccine for COVID-19.

    Enlarge / A picture taken on January 15, 2021 shows a pharmacist holding with gloved hands a vial of the undiluted Pfizer-BioNTech vaccine for COVID-19. (credit: Getty | JEAN-FRANCOIS MONIER )

    In a bit of good news, Pfizer and BioNTech announced today that their highly effective COVID-19 vaccine does not require ultra-cold storage conditions after all and can be kept stable at standard freezer temperatures for two weeks.

    The companies have submitted data to the US Food and Drug Administration demonstrating the warmer stability in a bid for regulatory approval to relax storage requirements and labeling for the vaccine.

    If the FDA greenlights the change, the warmer storage conditions could dramatically ease vaccine distribution, allowing doses to be sent to non-specialized vaccine administration sites. The change would also make it much easier to distribute the vaccine to low-income countries.

    Read 5 remaining paragraphs | Comments

    index?i=0-auRFYiJ90:CgcMq0XOxsA:V_sGLiPBpWUindex?i=0-auRFYiJ90:CgcMq0XOxsA:F7zBnMyn0Loindex?d=qj6IDK7rITsindex?d=yIl2AUoC8zA
    • chevron_right

      Pfizer, Feds reach deal for additional 100M COVID-19 vaccine doses

      Kate Cox · news.movim.eu / ArsTechnica · Wednesday, 23 December, 2020 - 19:53

    Extreme close-up photograph of fingers holding a tiny glass jar.

    Enlarge / A nurse in the UK holds a vial of the Pfizer-BioNTech COVID-19 vaccine on December 22, 2020. (credit: Lindsey Parnaby | AFP | Getty Images )

    The Federal government has reached a deal with drugmaker Pfizer to secure an additional 100 million doses of the Pfizer-BioNTech COVID-19 vaccine before the end of July, the company said today.

    Under the terms of the new agreement , the government will pay $1.95 billion for the additional doses. Of the new vaccine doses, 70 million are due by June 30, with the remaining 30 million to be delivered no later than July 31. The agreement also provides US authorities with the option to order up to 400 million additional doses of the vaccine later.

    Health and Human Services Secretary Alex Azar said in a statement that the additional Pfizer vaccine "can give Americans even more confidence that we will have enough supply to vaccinate every American who wants it by June 2021," when added to the 100 million doses the US government has already agreed to purchase from Pfizer, as well as the recently approved Moderna vaccine .

    Read 7 remaining paragraphs | Comments

    index?i=R_n_EuhRwyU:XymGThTxDyQ:V_sGLiPBpWUindex?i=R_n_EuhRwyU:XymGThTxDyQ:F7zBnMyn0Loindex?d=qj6IDK7rITsindex?d=yIl2AUoC8zA
    • chevron_right

      Pfizer reports final vaccine results: 95% efficacy

      Beth Mole · news.movim.eu / ArsTechnica · Wednesday, 18 November, 2020 - 14:56

    An illustration picture shows vials with Covid-19 Vaccine stickers attached, with the logo of US pharmaceutical company Pfizer, on November 17, 2020.

    Enlarge / An illustration picture shows vials with Covid-19 Vaccine stickers attached, with the logo of US pharmaceutical company Pfizer, on November 17, 2020. (credit: Getty | JUSTIN TALLIS )

    Pharmaceutical giant Pfizer and German biotech firm BioNTech announced Wednesday that they have wrapped up the Phase III trial of their COVID-19 mRNA vaccine, finding it to be 95 percent effective at preventing disease and consistently effective across age, gender, race, and ethnicity demographics. The vaccine appeared effective at preventing cases of severe disease as well.

    The companies added that they have also met a safety milestone—collecting a median of two months of safety monitoring data on trial participants—to file a request for an Emergency Use Authorization (EUA) with the US Food and Drug Administration. They plan to file the request “within days.”

    “The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic,” Dr. Albert Bourla, Pfizer Chairman and CEO, said in a statement. “We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world.”

    Read 9 remaining paragraphs | Comments

    index?i=NrlDSgVvnK8:uDe2BM1uhb8:V_sGLiPBpWUindex?i=NrlDSgVvnK8:uDe2BM1uhb8:F7zBnMyn0Loindex?d=qj6IDK7rITsindex?d=yIl2AUoC8zA
    • chevron_right

      More good COVID-19 vaccine news—but it won’t save us

      Beth Mole · news.movim.eu / ArsTechnica · Monday, 16 November, 2020 - 20:48

    Geneva: WHO Director-General Tedros Adhanom Ghebreyesus announced on March 11, 2020 that the new coronavirus outbreak can now be characterized as a pandemic.

    Enlarge / Geneva: WHO Director-General Tedros Adhanom Ghebreyesus announced on March 11, 2020 that the new coronavirus outbreak can now be characterized as a pandemic. (credit: Getty | FABRICE COFFRINI )

    There’s more good news on the COVID-19 vaccine front today: biotechnology company Moderna reported in a press release this morning that its mRNA vaccine appeared 94.5 percent effective at preventing COVID-19 in an interim analysis of a large, Phase III trial. The news comes exactly one week after similar results came out via press release for another mRNA vaccine developed by pharmaceutical giant Pfizer and German biotech firm BioNTech.

    But, while health experts are “cautiously optimistic” for this and many other vaccines in the coming months, they warn that such a timeline will not be fast enough to spare lives and health care systems from the current spike in disease.

    “Right now, we are extremely concerned by the surge in cases we’re seeing in some countries,” Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization, said in a press conference Monday. “Particularly in Europe and the Americas, health workers and health systems are being pushed to the breaking point.”

    Read 18 remaining paragraphs | Comments

    index?i=0KvvQXA9EGk:EfqVeZRk2ZQ:V_sGLiPBpWUindex?i=0KvvQXA9EGk:EfqVeZRk2ZQ:F7zBnMyn0Loindex?d=qj6IDK7rITsindex?d=yIl2AUoC8zA